EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  
(Text with EEA relevance)   EN 1  EN  COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to  Regulation (EC) No 1907/2006 of the Europ ean Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC ) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and  2000/21/EC1, and in particular Article s 
58 and 131 thereof,  
Whereas:  
 
(1) The substance  tetraethyllead  meets the criteria for classification as toxic for 
reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council2 and therefore meet s the criteria for inclusion 
in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57 , point (c), of that 
Regulation . 
(2) The substance 4,4' -bis(dimethylamino) -4''-(methylamino)trityl alcohol (with ≥ 0 ,1% of 
Michler's ketone (EC No 202 -027-5) or Michler's base (EC No 202 -959-2)) meets the 
criteria for classification as carcinogenic (category 1 B) in accordance with Regulation 
(EC) No 1272/2008 and therefore meet s the criteria for inclusion in Annex XIV to 
Regulation (EC) No 1907/2006 set out in Art icle 57 , point (a), of that Regulation.  
(3) Reaction products of 1,3,4 -thiadiazolidine -2,5-dithione, formaldehyde and 4 -
heptylphenol, branched and linear (RP -HP) (with ≥  0,1% w/w 4 -heptylphenol, 
branched and linear ) are substance s that ha ve endocrine disruptin g properties for 
which there is scientific evidence of probable serious effects to the environment . They 
give rise to an equivalent level of concern to those of other substances listed in Article 
57, points (a) to (e),  of Regulation (EC) No 1907/2006 and, therefore, meet the criteria 
for inclusion in Annex XIV to that Regulation set out in Article 57 , point (f), of that 
Regulation.  
(4) The substance 2-ethylhexyl 10 -ethyl -4,4-dioctyl -7-oxo-8-oxa-3,5-dithia -4-
stannatetradecanoate (DOTE)  meets the criteria for classification as toxic for 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1).  EN 2  EN  reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and 
therefore meet s the criteria for inclusion in Annex XIV to Regulation (EC) No 
1907/2006 set out in Article 57 , point (c), of that Regulation.  
(5) Reaction mass of 2 -ethylhexyl 10 -ethyl -4,4-dioctyl -7-oxo-8-oxa-3,5-dithia -4-
stannatetradecanoate and 2 -ethylhexyl 10 -ethyl -4-[[2-[(2-ethylhexyl)oxy] -2-
oxoethyl]thio] -4-octyl -7-oxo-8-oxa-3,5-dithia -4-stannatetradecanoate (reaction mass 
of DOTE and MOTE)  is a substance that meets the criteria for classification as toxic 
for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and 
therefore meet s the criteria for inclusion in Annex XIV to Regulation (EC) No 
1907/2006 set out in Article 57 , point (c), of that Regulation.  
(6) All the above -mentioned  substances have been identified as meeting the criteria 
referred to in Article 57 of Regulation (EC) No 1907/20 06 and included in the 
candidate list for eventual inclusion in Annex X IV to that Regulation. They have 
furthermore been prioritised for inclusion in that Annex by the European Chemicals 
Agency (“the Agency”) in its recommendation of 1 October 20193. 
(7) The Agency conducted a public consultation on its draft recommendation where  
interested parties were invited to submit comments. In addition, the Commission 
received submissions from interested parties to calls for information on the possible 
economic, social, health and environmental impacts (costs and benefits) of the 
inclusion in Annex XIV to Regulation (EC) No 1907/2006 of the substances proposed 
by the Agency in its draft recommendation.  
(8) The above -mentioned substances should therefore be included in Annex XIV to 
Regulation (EC) 1907/20 06. 
(9) For each  of the substances included in  Annex XIV to Regulation (EC) No 1907/2006  
by this Regulation , a date from which the placing on the market and the use of the 
substance is to  be prohibited unless an authorisation is granted should be set as 
required by Article 58(1) , point (c)(i) , of Regulation (EC) No 1907/2006, taking into 
account the Agency’s capacity to handle applications for authorisation. For each of 
those substances there are no  reasons why the date referred to in Article 58(1) , point 
(c)(ii), of Regulation (EC) No 1907/200 6 should be set earlier  than 18  months before  
the date referred to in Article 58(1) , point (c)(i) , of that  Regulation.   
(10) Article 58(1) , point (e), in conjunction with Article 58(2) of Regulation (EC) 
No 1907/2006 provides for the possibility of exemptions o f uses or categories of uses 
in cases where specific Union legislation imposes minimum requirements relating to 
the protection of human health or the environment ensuring proper control of the risks . 
In accordance with the information available , it is not appropriate to set exemptions 
based on those provisions.   
(11) During the public consultation conducted by the Agency on its draft recommendation, 
no specific comments were submitted with regard to possible exemptions for product 
and process orientated researc h and development . On the basis o f the information 
available , it is therefore not appropriate to set those exemptions.   
(12) As the available information on the uses of the substances  included in Annex XIV to 
Regulation (EC) No 1907/2006 by this Regulation  is limited, it is not appropriate to 
                                                 
3   https://echa.europa.eu/documents/10162/13640/9th_axiv_re commendation_October2019_en.pdf/d4d55dea -
cc36 -8f57-0d9f-33b8e64c4f07  EN 3  EN  set review periods referred to in Article 58(1) , point (d), of that Regulation  at this 
stage . 
(13) The substances 2-methoxyethanol  (EGME)  and 2-ethoxyethanol  (EGEE) meet the 
criteria for classification as toxic for reproduction (category 1B) in accordance with 
Regulation (EC) No 1272/2008 and therefore meet the criteria for inclusion in Annex 
XIV to Regulation (EC) No 1907/2006 set out in Article 57 , point (c), of that 
Regulation.  The placing on the market and use of both substances  on their own, as 
constituents of other substances or in mixtures  for supply to the general public are 
restricted  in accordance with Annex XVII to Regulation (EC) No 1907/2006 . As 
regards the protection of workers, indicative occupational exposure limit values  have 
been  established  for those substances  at Union level by Commission Directive 
2009/161/EU4 as provided for in Council Directive 98/24/EC5. As those  values are not 
binding , the implementation  of that Directive  by the Member States may vary. The 
Commission is assessing what could be the most appropriate  regulatory approach 
regarding  those substances . It is therefore appropriate to postpone the ir inclusion in 
Annex XIV to Regul ation (EC) No 1907/2006.    
(14) The substances  cyclohexane -1,2-dicarboxylic anhydride [1], cis -cyclohexane -1,2-
dicarboxylic anhydride [2], trans -cyclohexane -1,2-dicarboxylic anhydride [3]  (HHPA)  
and hexahydromethylphthalic anhydride [1], hexahydro -4-methylphthalic anhydride 
[2], hexahydro -1-methylphthalic anhydride [3], hexahydro -3-methylphthalic anhydride 
[4] (MHHPA) meet the criteria for classification as respiratory sensitiser  (category 1) 
in accordance with Regulation (EC) No 1272/2008 . The Agency concluded that there 
is scientific evidence of probable serious effects to human health which give rise to an 
equivalent level of concern to those of other substances listed in Article 57 , points (a) 
to (e),  of Regulation (EC) No 1907/2006  and that those substances  therefore meet the 
criteria for inclusion in Annex XIV to that Regulation set out in Article 57 , point (f), 
of that Regulation.  According to available information, t hose substances are used  at 
industrial sites , where the main concern is related to exposure  of workers  and there are 
no professional or consumer uses . As regards the protection of workers, there are no 
indicative occupational exposure limit values established  for those substances at Union 
level  in accordance with  Directive 98/24/EC , and it may be difficult to establish  a safe 
level of exposure for a respiratory sensitiser.  The Commission is assessing what could 
be the most appropriate  regulatory approach regarding  those substances . It is therefore 
appropriate to postpone the inclusion of th ose substances in Annex XIV to Regulation 
(EC) No 1907/2006.   
(15) The substance 1,6,7,8,9,14,15,16,17,17,18,18 -
Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca -7,15-diene (“Dechlorane 
Plus”™)  (covering any of i ts individual anti - and syn -isomers or any combination 
thereof ) is a very persistent and very bioaccumulative substance , in accordance with 
the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 , and therefore 
meets the criteria for inclusion i n Annex XIV to that Regulation set out in its Article 
57, point (e). An Annex XV  dossier  is under preparation to restrict uses of that  
substance . In addition, steps have been taken  towards the inclusion of that substance in 
                                                 
4  Commission Directive 2009/161/EU of 17 December 2009 establishing a third list of indicative 
occupational exposure limit values in implementation of Council Directive 98/24/EC and amen ding 
Commission Directive 2000/39/EC (OJ L 338, 19.12.2009, p. 87).  
5 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from 
the risks related to chemical agents at work (fourteenth individual Directive within  the meaning of 
Article 16(1) of Directive 89/391/EEC ) (OJ L 131, 5.5.1998, p. 11).  EN 4  EN  the Stockholm Convention on Persistent Organic Pollutants6. Once a substance is 
subject to the Convention, its manufacturing, placing on the market and use are to  be 
prohibited , phased out as soon as possible  or restricted at Union level by Regulation 
(EU) 2019/1021 of the European P arliament and of the Council7. Substances for which 
all uses have been prohibited  by other Union  legislation cannot be listed in Annex XIV 
to Regulation (EC) No 1907/2006 . In order to ensure a consistent regulatory approach, 
the outcome of those initiative s should be taken into consideration prior to taking a 
decision on  the inclusion of “Dechlorane Plus”™  in Annex XIV to Regulation (EC) 
No 1907/2006 . It is therefore  appropriate to postpone the inclusion of that substance in 
Annex XIV to Regulation (EC) 1907/2006.  
(16) The seven lead compounds dioxobis(stearato)trilead ; fatty acids, C16 -18, lead salts ; 
trilead dioxide phosphonate ; sulfurous acid, lead salt,  dibasic ; [Phthalato(2 -
)]dioxotrilead ; trilead bis(carbonate) dihydroxide and lead oxide sulfate meet the 
criteria for classification as toxic for reproduction (category 1A) in accordance with 
Regulation (EC) No 1272/2008 and therefore meet the criteria for inclusion in Annex 
XIV to Regulation (EC) No 1907/2006 set o ut in Article 57 , point (c), of that 
Regulation.  Those substances are mainly  present in recycled polyvinyl chloride (PVC ) 
and cannot be removed  with the current technology . The Commission is working on a 
Regulation  to prohibit  the use of lead and its compo unds  in PVC articles and restrict 
the placing on the market of PVC articles containing more th an 0,1% lead, with some 
derogations.  Furthermore, the current Union binding occupation al exposure  limit value 
and binding biological limit value for lead compounds  established  under Directive 
98/24/EC  are under review. Therefore, in view of the ongoing discussions on 
restriction of  use of  lead and its compounds as well as possible adoption of more 
stringent measures at the workplace, it is appropriate to po stpone a decision on the 
inclusion of th ose substances in Annex XIV to Regulation (EC) 1907/2006 . 
(17) The substance 4,4'-isopropylidenediphenol (B isphenol A; BPA) meets the criteria for 
classification as toxic for reproduction (category 1B) in accordance with Regulation 
(EC) No 1272/2008. It also ha s endocrine disrupting properties for which  there is 
scientific evidence of probable serious effects to human health and the environment.  It 
gives rise to an equivalent level of concern to those of other substances l isted in 
Article 57 , points (a) to (e),  of Regulation (EC) No 1907/2006 . It therefore  meets the 
criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in 
Article 57 , points (c) and (f) , of that Regulation.  An Annex XV dossier is under 
preparation to restrict the use of Bisphenol A and structurally related bisphenols of 
similar concerns for the environment. That restriction is to cover  the uses of Bisphenol 
A that would fall under the authorisation regime. It is therefore appropriate to 
postpone the inclusion of that substance in Annex XIV to Regulation (EC) 
1907/2006. Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(18) The measures provided for in this Regulation are in accordance with the opinion of the  
Committee  establ ished by Article 133 of Regulation (EC) No 1907/2006 , 
                                                 
6 OJ L 209, 31.7.2006, p. 3.  
7  Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on 
persistent organic pollutants (OJ L 169, 25.6.2019, p. 45).  EN 5  EN  HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2 
This Regulation shall enter into force on the  twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN